STANDARDISATION AND QUALITY CONTROL OF HERBAL FORMULATIONS

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What is quality? What is quality control? How are both determined?

Quality is determined by examining the actual ingredient used in the final product of the formulation made for consumption. Quality control is basically the entire production process and whether the final product is fit for consumption or not.

Standardisation and quality control are both needed in today’s modern world. In ancient times medication was taken on a trial and error basis and the shamans or medicine men were treated with the highest honour and whatever they pronounced was taken at face value. These days however, there is quality control on every product because there needs to be some sort of scale for measuring whether something is safe to consume and in what quantity.

Even when it comes to herbal medication, it cannot be taken in any quantity because some other side effect may occur. Also, the dosage would be different for adults and for children. Also, how these herbs are grown and obtained and whether there are satisfactory manufacturing processes is also a necessity even though it involves natural substances.

There are three pillars when it comes to quality control and standardisation of herbal formulations: Availability, Accessibility, Quality.

The World Health Organisation (WHO) has set up and published guidelines for standardisation of commercial use of herbal medication. If you read through these publications you will see that they are very detailed and above all, very stringent. This is so because the actual growth of herbs that are the main ingredients can be controlled but only to a certain extent. Mainly because they thrive in nature. While over-the-counter pills are processed 100% in a laboratory, everything can be controlled and standardised. But this is not so for herbal medication. Also, herbs are sought from particular regions of the world where they have been growing for centuries, so it is difficult to put guidelines on their growth.

Wide commercial use of herbs for medicinal purposes is quite a recent phenomenon, so standardisation processes are not cemented yet, but they are in the process. In many European countries, it has already been established, but the US is yet to keep up to that pace, mainly because people are still heavily dependent on pills and also because giant pharmaceutical companies are forcing herbal formulations to the back burner. However, it is possible that one will see this growth and legal guidelines in the near future.

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